Investigating efficacy and safety of Gluronic acid capsule in patients with moderate to severe COVID-19
Design
a multi-center, randomized, open-labeled, controlled, parallel phase 3 clinical trial
Settings and conduct
Patients who will admitted to Chamran, Baqiyatallah or Farhikhtegan hospital and will meet the inclusion criteria, will be entered to the study, and will randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria:confirmed diagnosis of COVID-19; the written consciously and freely consent to participate in the study; moderate to severe Corona-Virus associated pneumonia; in the first 48 hours after his/her inclusion, there is no possibility of discharge from hospital.
Exclusion criteria: Pregnancy; Lactation; The patient is involved at another clinical trial at the same time; Severe renal impairment; Severe hepatic impairment; Severe heart failure; uncontrolled diabetes; active infection; active cancer; coagolupathy; primary immunodeficiency syndrome.
Intervention groups
Capsule Gluronic acid 500mg, 2 capsule every 12 hours, after meal, for 4 weeks; in addition to routine treatment according to the latest national guideline.
Main outcome variables
Need to receive ICU service rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N64
Registration date:2021-05-21, 1400/02/31
Registration timing:prospective
Last update:2021-05-21, 1400/02/31
Update count:0
Registration date
2021-05-21, 1400/02/31
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19
Public title
Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient/Legal guardian has written consciously and freely consent to participate in the study;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;
Moderate to severe COVID pneumonia
Exclusion criteria:
Pregnancy
Lactation
The patient is present at another clinical trial at the same time.
Severe renal impairment
Severe hepatic impairment
Severe cardiac impairment
Uncontrolled diabetes
Active infection
Active cancer
Coagulopathy
Primary immunodeficiency syndrome
Allergy to Glurunic acid
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Need to receive ICU service rate (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12)
Timepoint
Daily
Method of measurement
Clinical assessment
Secondary outcomes
1
Description
Mortality rate
Timepoint
30 days after including the study
Method of measurement
Clinical assessment
2
Description
Length of hospitalization
Timepoint
The first day and the end of hospitalization
Method of measurement
The hospital record review
3
Description
Laboratory changes
Timepoint
Daily until discharge
Method of measurement
Blood sample, laboratory analysis
4
Description
Fever
Timepoint
Daily until discharge
Method of measurement
Clinical assessment
5
Description
Respiratory distress
Timepoint
Daily until discharge
Method of measurement
Clinical assessment
6
Description
Oxygen saturation without receiving oxygen supplement
Timepoint
Daily until discharge
Method of measurement
Pulse-oxymetery device
7
Description
Side effects
Timepoint
Daily during hospitalization, weekly after discharge
Method of measurement
During hospitalization by clinical evaluation, after discharge by telephone follow-up
Intervention groups
1
Description
Intervention group: Guluronic acid (G2013) capsule 500 mg, 2 capsules every 12 hours, after meal, for 4 weeks; in addition to routine treatment according to the latest national guideline.
Category
Treatment - Drugs
2
Description
Control group: routine treatment according to the latest national guideline.